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Completed

NCT Number: NCT01001403

Effect of Nafamostat on Postreperfusion Syndrome (PRS)

This study intends to see the effect of nafamostat on the attenuation of postreperfusion syndrome (PRS) that frequently occurs during liver transplantation.

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Key information

Conditions

Liver Transplantation Postreperfusion Syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >= 18 year old scheduled to undergo liver transplantation

Exclusion criteria

  • Previous history of pulmonary, cardiovascular, or renal disease
  • Previous history of allergic reactions to nafamostat

Treatment and study plan

Nafamostat

Drug

0.2 mg/kg as bolus 1 minute before reperfusion

normal saline

Drug

10 ml of normal saline

Primary outcomes

  1. Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS)

    Time frame: during 5 min after reperfusion of liver graft

    Before entering the study, we re-defined the criteria of PRS. From our clinical experiences, two types of PRS were observed according to its severity and treatment option. "Moderate" PRS was identical to previously defined PRS: more than 30% decrease of mean arterial pressure lasting over 1 min was observed within 5 min after reperfusion of the liver graft. However, we differentiated a "severe" form of PRS, in which MAP rapidly fell below 40 mmHg, from the moderate one, because severe PRS required prompt intervention to prevent a permanent damage of vital organs.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of Nafamostat Mesilate on Hemodynamic Stability After Reperfusion of the Liver Graft

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 26, 2009
Registry last updated
May 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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